IMPIX ALIF — Class II medical device recall Z-2453-2023
Ongoing recall by Medicrea International, reported 2023-08-30, distributed nationwide. There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the in
| Recall number | Z-2453-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medicrea International, Rillieux La Pape, N/A, France |
| Recall initiated | 2023-07-12 |
| Classified | 2023-08-24 |
| Reported by FDA | 2023-08-30 |
| Distributed | Nationwide (US) |
| Quantity | 11 units |
| UPC / GTIN / UDI-DI | 03613720193395, 03613720193401, 03613720193425, 03613720193432 |
| Lot numbers | 19C0772, 19C0775, 19C0788, 19E0353, 19G0070 |
Product
IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
Reason for recall
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2453-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.